A new study has introduced a new chip-based technology that shows potential in addressing the diagnostic challenges posed by tuberculosis (TB), particularly in identifying the "missing millions" of undiagnosed cases worldwide.
The research, conducted by a collaboration between St. George's University of London, the Institute for Infection and Immunity, and QuantuMDx, a UK-based medical technology company, aims to develop an affordable, rapid, accurate, and portable TB diagnostic test to analyze sputum samples for Mycobacterium tuberculosis (Mtb) in suspected TB patients.
Chip-based Tech
Lead investigator Dr. Philip D. Butcher from St George's, University of London, highlighted the urgent need for improved TB diagnostics, stating, "The global burden of TB is not improving. Although it is infectious, it is highly treatable."
"However, affordable diagnostics suitable for implementation at the point of care are needed to reach the 'missing millions.'"
To address this challenge, the research team collaborated on a chip-based technology utilizing dielectrophoresis, a technique that selectively isolates Mtb bacilli from sputum samples.
The team developed a prototype microfluidic lab-on-a-chip system known as CAPTURE-XT, provided by QuantuMDx, which processes solubilized sputum and captures Mtb bacilli for visual analysis, molecular confirmation using quantitative PCR (qPCR), and subsequent genotypic drug-susceptibility analysis.
CAPTURE-XT exploits the principle of dielectrophoresis, allowing the selective attraction and concentration of Mtb bacteria while removing other sputum contents.
After optimizing the prototype using a set of 50 characterized sputum samples, the researchers conducted a blinded screening of 100 characterized and bio-banked sputum samples.
The results were impressive, with a perfect concordance rate of 100% for samples that tested negative in smear microscopy and an 87% concordance rate for smear-positive samples.
Notably, among smear-positive samples with a high bacterial burden, the concordance rate reached 100%.
Sample Preparation Tool
These findings highlight the technology's potential as a robust sample preparation tool, enhancing molecular detection capabilities and offering a cost-effective visual diagnostic method.
Dr. Jonathan O'Halloran, the Chief Executive Officer of QuantuMDx Group Ltd, commended the groundbreaking nature of the CAPTURE-XT technology and underscored its capacity to substantially enhance access to accurate diagnoses for millions of individuals.
He explained how this chip-based technology replaces conventional smear microscopy techniques, providing visual readouts with heightened sensitivity and lower costs. Dr. O'Halloran also emphasized the versatility of the technology, envisioning its application in addressing various diseases beyond tuberculosis.
Tuberculosis remains a significant global health threat, causing millions of infections and deaths each year, particularly among children.
The introduction of this chip-based technology holds promise not only in improving TB diagnostics but also in addressing drug resistance and detecting low-bacterial burden cases.
By increasing sensitivity and expanding drug susceptibility testing, this innovation has the potential to make a significant impact on the fight against TB.
The findings of the team were published in the Journal of Molecular Diagnostics.
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